Inspection Technician (Internal Fill/Finish MFG)

Role Summary

Inspection Technician (Internal Fill/Finish MFG) performs visual inspection of liquid and lyophilized vials and liquid syringes, operates semi-automated and fully automated inspection equipment, and supports documentation and training to maintain cGMP standards. The role involves working individually and as part of a team, developing proficiency in a range of processes, and providing recommendations and guidance to colleagues.

Responsibilities

• Performs the visual inspection of liquid and lyophilized vials and liquid syringes using manual inspection booths and/or semi-auto inspection machines.
• Operates automatic inspection equipment.
• Performs line clearance and cleaning activities of inspection booths and semi-auto and auto inspection machines.
• Supports the load and unload of inspection equipment when not performing visual inspection activities.
• Reviews, edits, completes and revises completed batch records, logbooks and SOPs in accordance with cGMP standards and compliant with written procedure.
• Completes training and maintains required qualifications for visual inspection.
• Coordinates to ensure process areas are stocked with essential equipment and components and ensures equipment and process operational readiness.
• Reconciles components and product according to SOP and Batch Record requirements.
• Ensures all tasks are performed in a manner consistent with cGMP SOPs and safety standards.
• Participates in equipment start-up, commissioning and validation activities.
• Assists with troubleshooting in case of equipment failure.
• Gathers, trends, and analyzes process generated data.
• Supports investigations associated with internal inspection activities.
• Documents all training.
• Assists with training of new employees as directed.
• Assists and contributes in all areas of visual inspection as needed.
• Travel (domestic and international) may be required to support new equipment purchases and/or training.

Qualifications

• You are able to pass a visual acuity exam according to SOP requirements.
• You have knowledge of a cGMP manufacturing environment and familiarity with visual inspection of liquid and lyophilized products.
• You demonstrate strong interpersonal, cross-cultural, communication, negotiation and problem-solving skills.
• You exhibit confidence, have a high emotional IQ and demonstrated ingenuity, creativity and resourcefulness.
• You are able to gain understanding from provided instructions and work towards established goals individually or as part of a team.
• You understand and listen to team members and stakeholders’ needs while supporting a positive team environment.
• Visual acuity requirements include Near Vision Acuity (Jaeger Test) - 20/20 (with or without corrective lenses) and Colorblindness Test (Ishihara Test) – 14/14 prior to start date.

Education

• Level I - HS diploma/GED/Leaving Cert; 0-2 yrs experience; college degree may be preferred
• Level II - HS diploma/GED/Leaving Cert; 2+ yrs experience; college degree may be preferred
• Level III - HS diploma/GED/Leaving Cert; 4+ yrs experience; college degree may be preferred
• Level IV - HS diploma/GED/Leaving Cert; 6+ yrs experience; college degree may be preferred

Additional Requirements

• Travel (domestic and international) may be required to support new equipment purchases and/or training.
• Must be able to lift/push/pull at least 40 lbs.